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Approval of labeling changes for the pathway her-2/neu (clone cd11) in the "intended use" section, addition of an "optional equipment not provided" section and changes to the "principles and procedures" section to reflect the addition of tripath imaging vias instrument to be used in conjunction with the ventana pathway her 2 assay as an optional accessory. The device, as modified, will be marketed under the same trade name patyhway her-2/neu (clone cd11) and is indicated: ventana medical systems, inc.'s (ventana) pathway her 2 (clone cd11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbb2- antigen in sections of formalin fixed, paraffin embedded normal and neoplastic tissue on a ventana automated immunohistochem-istry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom herceptin treatment is considered. Note: all of the patients in the herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using pathway her 2. The pathway her 2 was compared to the dako herceptest on an independent sample and found to provide acceptably concordant results. The actual correlation of pathway her 2 to clinical outcome has not been established. The ventana image analysis system (vias) is adjunctive optional computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection classification and counting of cells of interest based on market intensity, size and shape using appropriate controls to assure the validity of the vias scores.
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